All of Us Biobank - ROA Webinar_Slides.pdf

All of Us Research Program Research Opportunity Announcement Informational Webinar ROA No. OTA-25-002

All of Us Biobank Date: December 3, 2024; 1:00 PM–2:30 PM ET All of Us Research Program

Today’s Presenters

Mark Caulder Deputy Chief Cohort Development Officer

All of Us Division of Cohort Development

Sarah Yang All of Us Biobank Program Officer

All of Us Division of Cohort Development

Debra Sowell Other Transactions Agreements Officer

All of Us Awards Management Branch

Webinar Agenda: All of Us Biobank Research Opportunity Announcement (ROA)

• Provide an overview of the All of Us Research Program

• Highlight the current All of Us Biobank’s scope and scale

• Outline the All of Us Biobank ROA requirements o Purpose and overview o Award structure and associated programmatic milestones

• Review the submission requirements, proposal evaluation criteria, and timelines

• Question and answer session

All of Us Research Program Overview

All of Us Research Program Mission

Our Mission Accelerate health research and medical breakthroughs, enabling individualized prevention, treatment, and care for all of us

Nurture partnerships for decades with at least a million participants who reflect the diversity of the U.S.

Deliver one of the largest, richest biomedical datasets that is broadly available and secure

Catalyze an ecosystem of communities, researchers, and funders who make All of Us an indispensable part of health research

Made possible by a team that maintains a culture built around the program’s core values

All of Us Research Program Strategic Goals

Enroll 1 million participants who reflect the diversity of the United States, cover the lifespan, and have shared all baseline elements. Of these, at least 500,000 participate in ongoing data donation opportunities.

Expand the data available for 1 million participants, to include surveys, health data streams, a whole genome sequence, environmental data, and physical measures.

Launch partnered research studies as a core and scalable capability, that expands the cohort and delivers new phenotypic, lifestyle, environmental, and biological data.

Establish a diverse global community of 10,000 researchers productively using All of Us data.

Incorporate participant return of value into data collections and assess its impact, including return of information to participants on genomics and EHR.

Enable the full potential of the All of Us Research Program through organizational accountability, strategic and data-driven decision-making, effective core processes, and team capacity and development.

All of Us Consortium Members and Partners

100+ Funded Partner Organizations

750+ Sites Collecting Samples and Measurements

Outreach These counts represent the numbers of programs partner awardees and enrollment sites launched.

These numbers are updated on an as-need basis.

Health Care Provider Organizations (HPOs) Network Community and Provider Partner Network Communications and Engagement

Participant and Partner Services Center (PPSC) Data Research Center (DRC) Genomics Centers

Status of All of Us Participants (as of November 4, 2024)

Participant Enrollment

845,000+ Participants

453,000+ Electronic Health

Records

573,000+ Participants who have completed initial steps of the program

594,000+ Biosamples

All of Us Supports Regional Enrollment Centers & Nationwide Virtual Participation

All of Us supports nationwide enrollment in all 50 states and U.S. territories through a combination of virtual recruitment, regional enrollment centers, and interactive mobile exhibits. Participants can currently enroll and participate in English or Spanish.

787800

All of Us Strives to Enroll a Cohort that Reflects the Diversity of the U.S.

Self-Identified Race & Ethnicity of Participants UBR Category

Over 87% of All of Us participants are underrepresented in biomedical research

Numbers current as of November 1, 2024

Data from Participants Provided to Researchers AND Back to Participants

From Participants

Electronic health records

Participant surveys

Physical measurements

Biosamples

Mobile/wearable tech

To Researchers

287,000+ With EHR data

413,350+ With survey responses

337,500+ With physical measures

245,350+ With short-read whole genome sequences (WGS)

15,600+ With Fitbit records

Back to Participants

Survey & health data

Physical measurements

DNA results

Scientific findings

Data as of April 2023 Curated Data Repository (CDR) v7 data release

Current All of Us Biobank Scope and Scale

Biobank Mission and Scope

All of Us Biobank Mission

• To support the collection, processing, storage, access, and distribution of high quality and diverse biospecimens, which can be used to address a wide range of scientific questions to promote the acceleration of health research, medical breakthroughs, and improve public health.

Biobank Scope and Scale

• 1 million or more participants who reflect the diversity of the U.S.

• Capacity to process, store and distribute 32M+ aliquots

Blood (primary), saliva (backup), urine

• Biospecimen access - All of Us Ancillary Studies

• Pediatric enrollment

• Longitudinal cohort with biospecimen-related reassessments

Biobank Current Responsibilities

Provide support in creating Standard Operating Procedures

(SOP)

Provide site training for biospecimen collection and logistics

Provide collection kits and leverage existing sample shipment logistics

Utilize our existing state-of-the-art laboratory to process, label, and store biospecimens

Use our high-quality, robust, and secure research laboratory information management system (RLIMS) for detailed tracking of samples

Work closely with the DRC, the Collection Sites, and all other Integrated Network Members to share biobanking expertise, infrastructure, and data to help achieve the goals of the Program

Apply our comprehensive Quality Management Program to ensure all work carried out is of the highest quality

Established Adult Biospecimen Collection Workflows

Established Pediatric Biospecimen Collection Workflow

Current All of Us Adult Biospecimen Collection, Processing, and Storage Schema (As of 11/4/2024)

Collection Tube [Sample Type] Type of Aliquot Primary Tubes Received Aliquots Stored

Serum Separator (SST) [blood] Serum 474,158 1,781,242

Plasma Separator (PST) [blood] Plasma 473,965 1,853,692

Sodium Heparin [blood] Whole Blood 474,340 943,148

EDTA [blood] DNA 474,158 1,071,252

EDTA [blood] Plasma 1,021,580 2,480,768

EDTA [blood] WBC 1,021,580 496,743

EDTA [blood] RBC 1,021,580 1,033,193

PAXgene Cell Free (ccfDNA) [blood] Plasma 442,274 438,776

PAXgene RNA [blood] RNA 443,222 10,690

PAXgene RNA [blood] Whole Blood 443,222 433,160

Urine Urine 479,360 3,727,327

Saliva DNA 115,673 183,924

Biobank Biospecimen and Data Flows

Biobank Biospecimen Quality Dashboard

• Evaluate biospecimen quality

• Identify biospecimen collection issues

• Monitoring sites and providing data to NIH Program Officers for milestones evaluation

• Proactively identify performance patterns and trends

• Data-driven conversations with All of Us collection sites and partners regarding biospecimen collection workflows, best practices, and lessons learned

How Biobank Supports All of Us Research Program

• Pediatric Enrollment o Soft launch for enrollment in December of 2023 o Development biospecimen collection protocol and SOPs

• Nutrition for Precision Health o Examine individual differences observed in response to different diets by studying the interactions between diet, genes, proteins, microbiome, metabolism, and other individual contextual factors o Develop new types of biospecimen collection protocols, SOPs and process workflows o Establish interactive QC/QA biospecimen collection dashboard

• All of Us Biospecimens Related Ancillary Studies o COVID serology study

• All of Us Multiple Omics Projects o Genotyping Arrays and Whole Genome Sequencing o Long-read Genome Sequencing o Proteomics o RNA Sequencing

Support Sustainable Growth of All of Us Ancillary Studies

A streamlined approach to stewarding broad availability of biospecimens

Prioritize assays and collaborations across studies to increase data availability

Increase biospecimen availability data in the Data Browser and Researcher Workbench

Plan opportunities for investigators to access a cohort of biospecimen aliquots simultaneously to reduce freeze/thaw cycles and streamline pull processes

All of Us Biospecimens at the Biobank as of 11/4/2024

3,924,572 Total Primary Biospecimens

Blood: 3,329,539 Urine: 479,360 Saliva: 115,673

14,453,915 Total Aliquots Stored

Example:

X01 Call for Biospecimen Use Cases

All of Us is thawing 100,000 plasma samples with XYZ characteristics and demographics.

Submit proposals for ancillary studies that would use them.

ROA Purpose, Overview, Structure, and Highlights

Purpose of the ROA

The purpose of this announcement is to solicit and review proposals, evaluate potential partners, and ultimately fund an All of Us Biobank to support the biospecimen collections, processes, workflows, methods, services, long-term storage, access, and distribution of high-quality diverse biospecimens leading to the generation and dissemination of data derived from these samples.

● Infrastructure: Maintain Existing Biospecimens while Sustaining and Enhancing Biobank

Operations

● Biobank Expansion: Pediatric, Reassessment, and Ancillary Studies

● Collaboration and Support: All of Us Research Program and Partners

All of Us Biobank Overview and Award Structure

Three primary functional teams

● Biospecimen Laboratory with Research Development Team

○ Biospecimen Laboratory

○ Biospecimen Research Development

● Biobank Logistics Team

● Training and Support Team

NIH expects that the proposal describes the structure, partnerships, and staffing to perform core functions and tasks.

Biospecimen Laboratory with Research Development Team: Biospecimen Laboratory

❖ NIH requires the proposer to propose solutions for promptly adapting to the established Biobank infrastructure, biospecimen workflows, pipelines, integrations, services, tools and processes to establish a scalable laboratory with core capabilities to ensure the continuity and sustainability of biobanking operations o Biospecimen processing capacity: Establish and maintain state-of-the-art laboratory and IT infrastructure, capable of supporting on average 800-1,200 participant collections per day, with highly automated and scalable workflows for processing, labeling, aliquoting, storing, and distributing high-quality and highly diverse biospecimens o Data management and security: Utilize a robust, high-quality, and secure laboratory information management system for detailed tracking of de-identified specimen receipt, processing, storage, retrieval, and distribution, while protecting participant confidentiality o Quality Assurance: Implement a comprehensive Quality Management Program to ensure the highest standards in all processes, and safeguard the collection with robust backup systems, plans for disaster recovery, and a geographically dispersed secondary biospecimen storage location

NIH expects that the proposal describes the facility capacities and capabilities required to support scalable, automated workflows that addresses current program needs and enables future growth.

Biospecimen Laboratory with Research Development Team: Research Development

❖ NIH seeks proposers capable of innovating and applying novel or emerging technologies, techniques, and processes to further scale and expand the Biobank’s capabilities in three distinct programmatic areas o Pediatrics: Develop and evaluate pediatric biospecimen collection devices and methods;

Innovate and refine biospecimen collection strategies to meet the evolving needs of pediatric research o Adult Participant Reassessment: Develop standardized re-assessment protocols, workflows and innovative methods to collect biospecimens from diverse and remote populations o Ancillary Studies: Expand Biobank Research and Development (R&D) efforts to support a wide range of ancillary studies, necessitating comprehensive R&D development and active involvement within the broader ancillary studies framework; Advance biospecimen processing pipelines to meet the complex requirements of cutting-edge multi-omics technologies

Biobank Logistics Team: Overview

❖ NIH seeks the proposers capable of providing established collection kits, bulk biospecimen collection supplies, and daily domestic sample courier and carrier shipment logistics across 50 states and U.S. territories to ensure specimens arrive and are processed in the most expedient, efficient, and safe manner possible, in accordance with all federal and state regulations

NIH expects that the proposal describes

● Establish a logistics plan, including detailed cost analysis, courier selection for biospecimen transport, and mitigating associated challenges across all 50 states and US territories

● Develop a centralized order management system to streamline the distribution of bulk biospecimen collection supplies to all active collection sites

● Develop a systematic strategy for proactively estimating and projecting future supply usage, ensuring an optimal balance between timely provision of essential supplies and minimizing waste by monitoring the expiration of unused materials

Biobank Training and Support Team: Overview

NIH expects that the proposal describes

● Biobank Dashboards: The proposer is expected to develop and maintain robust IT dashboards, which provide real-time monitoring and analytics of all aspects of the biospecimen workflow, including collection, processing, quality control, storage, and distribution activities. These dashboards should integrate seamlessly with existing data systems and offer user-friendly interfaces for tracking key performance indicators, ensuring transparency, and facilitating decision-making processes across the program.

● Training: The proposer is responsible for providing comprehensive training programs tailored to the specific needs of the collection workflows, methods, and logistics. These training initiatives should equip All of Us staff across all partner sites with the necessary knowledge and skills to implement biospecimen collection workflows in accordance with the program's standards, ensuring consistency and quality in every step of the process.

● Development of Documents: The proposer must develop and maintain a suite of essential documents, including Standard Operating Procedures (SOPs), incident reports, and Material Transfer Agreements (MTAs). These documents are critical to ensuring standardized operations, effective incident management, and the legal and ethical transfer of biospecimens between entities, thereby upholding the integrity and reliability of the program's operations.

Relationship Between Existing Biobank and New Biobank

● The structure of the planned Biobank award significantly extends the expectations for future Biobank expansion capabilities and research support services that will be necessary for the program’s continued growth.

● We are initiating the process to establish the new All of Us Biobank award at this time to ensure a timely and seamless process to compete, select, and transition program support from the existing Biobank award to the future All of Us Biobank award.

● The transition of award mechanism will be executed regardless of the ultimate outcome of the new Biobank competition.

● NIH expects the newly awarded biobank to adapt existing biospecimen collection workflows, processing protocols and pipelines, while ensuring the safe transfer of over 14 million biospecimen collections to the designated storage location.

High-Level Strategic Phase Plan for Existing Biobank Transition

Phase Scope and Goal

Phase 0 Onboarding and Planning: Access/review existing biobank related resources; Engage key partners;

Develop a comprehensive transition plan with milestones, roles, risk management and contingencies.

Phase 1 Establish and Development: Establish new infrastructure and logistics network; Integrate Laboratory Information Management System

Phase 2 Testing and Pre-launching: Conduct extensive testing to ensure data accuracy and accessibility;

Conduct pilot tests for newly developed infrastructure and workflows; Mock transport and storage tests for biospecimen integrity during the transfer

Phase 3 Launching and Training: Operational handover; Continuous monitoring and issue resolution; Batch transfer of biospecimens and minimize risk; Provide training and support; Implement optimization

NIH expects a seamless transition of existing biobank operations to the new biobank infrastructure with minimal disruption to ongoing research and biospecimen integrity.

All of Us Biobank Award Base Period with Transition Phases (12 months) Milestones 1–6

All of Us Biobank Award Base Period with Transition Phases (12 months) Milestones 7–11

Submission Requirements & Timeline

People Have Different Disease RisksAward Information

● Award Type: Other Transactions (OT)

● OT Authority: Granted to the NIH Director under the 21st Century Cures Act, as specified in Section 402(n) of the Public Health Service Act, 42 U.S.C. 282(n)

● Budget: Range from $13 million and up to $50 million (Year 1)

● Period of Performance

○ Initial award period (Year 1) will be twelve (12) months

○ May include up to four (4) 12-month yearly renewals

People Have Different Disease RisksCompetition Process

● This Other Transactions Award competition process will include three phases:

○ Phase I - Submission and Evaluation of Full Technical Proposal

○ Phase II - Biospecimen Laboratory, Storage and Research & Development Capabilities Demonstration and Evaluation, and Cost/Budget Proposal Submission (Invitation Only)

○ Phase III - Negotiation and OT Award (Invitation Only)

● The NIH intends to down-select at each phase resulting in making one OT award in Phase III

● Depending on program requirements, the NIH reserves the right to omit Phase II, or to combine the Phase submissions as needed

● For selected proposals invited to Phase II and III further instructions will be provided

● Participation in Phase I is required to be eligible for invitation to Phase II and III

Letter of Intent

• Requesting that proposers who intend to submit a proposal in response to the All of Us Biobank ROA complete the Intent to Submit Proposal Form (ROA Appendix B) and return to AllofUsDCDAwardRequirements@nih.gov by 09 December 2024, 10 a.m. EST

• Letter of Intent is not binding and does not enter into the review of a subsequent proposal

• Letter of Intent is not required but allows the All of Us Research Program to estimate the potential review workload and plan the review mailto:AllofUsDCDAwardRequirements@nih.gov

Phase I - Proposal Submission Instructions, Part 1

● Full technical proposal must be submitted via the NIH eRA ASSIST System

● To submit a proposal via ASSIST, the applicant organization must be registered in eRA Commons.

○ Please plan accordingly, as registration approval does not occur immediately upon request.

○ Organizations already registered in eRA Commons do not need to reregister.

○ The individual(s) with the role of Signing Official (SO) and Program Director/Principal Investigator (PD/PI) must be affiliated with the organization and have eRA Commons credentials to complete the submission process

● Use the ROA number, OTA-25-002, in the field requesting “Funding Opportunity Announcement #”

● Instructions for submitting a proposal in eRA ASSIST can be found at https://www.era.nih.gov/help-tutorials/assist/era-training-assist.htm

● eRA Technical help is available at https://www.era.nih.gov/need-help https://www.era.nih.gov/help-tutorials/assist/era-training-assist.htm https://www.era.nih.gov/help-tutorials/assist/era-training-assist.htm https://www.era.nih.gov/need-help

Phase I - Proposal Submission Instructions, Part 2

● Full technical proposal due 27 December 2024, 3:00 p.m. EST

● Proposal Submission Requirements

○ Paper Size: 8.5 x 11 inch paper

○ Margins: 1 inch on all sides

○ Spacing: single-spaced

○ Font: Times New Roman, 12 point

Note: Smaller text for charts, tables, figures, and illustrations is acceptable, as long as it is legible when the page is viewed at 100%.

○ Adobe PDF files are required for eRA ASSIST submission Note: MS Office formats may be requested post submission, if necessary for in-depth review (e.g., Excel spreadsheets to verify calculations

● One proposal submission per proposer

Phase I - Proposal Content Requirements

● Proposal Content

○ Cover page: does not count against page limit

○ Table of Contents: does not count against page limit

○ Abstract: not to exceed 1 page total

○ Specific Aims: not to exceed 1 page total

○ Team Structure and Partnerships: not to exceed 3 pages total

○ Leadership and Management Plan: not to exceed 3 pages total

○ Technical Approach: not to exceed 30 pages total

○ Milestone Plan: not to exceed 4 pages total

○ Transition Plan: not to exceed 6 pages total

○ Relevant Past Experience: not to exceed 4 pages total

○ Key Personnel Overview: not to exceed 3 pages total

○ Appendix 1: Key Personnel NIH Biosketches and Resumes Principal Investigator and/or Program Manager: for each, a maximum four-page NIH biosketch Other key personnel: for each, a two-page resume.

The biosketches and resumes in Appendix 1 do not count against the page limit.

Phase I Proposal Evaluation Criteria

• Proposals will be scored on the following evaluation criteria:

o Team

Each team will be assessed along four dimensions including:

Team Understanding Facility Capacities and Logistical Network Past Experience o Schedule The milestone plan will be assessed for the ability to satisfactorily meet the schedule of milestones.

• A numerical scoring system will be used in the technical evaluation of each proposal.

o Evaluators score each proposal on five elements (teams, understanding, facility capacity & logistic network, past experience, and milestone plan) to produce a composite score for a proposal.

• The NIH does not intend to provide feedback/debriefings on proposal submissions.

• Proposers will receive notification should the All of Us Research Program decide not to provide an invitation for the next Phase.

Note: To be eligible for invitation to subsequent Phases and award, proposers must submit a Proposal in Phase I.

People Have Different Disease RisksPhase II and Phase III (Invitation Only)

● Phase II - Biospecimen Laboratory, Storage and Research & Development Capabilities Demonstration and Evaluation, and Submission of Cost/Budget Proposal (Invitation Only)

○ This phase is by invitation only

○ The primary purposes for the Phase II Capabilities Demonstration and Evaluation is to better understand the composition and abilities of the proposer’s team, to assess automated laboratory and scalable storage readiness, and demonstrate the proposer’s facility (Details for requirements of technical demonstration will be provided to the proposer(s) in the invitation for Phase)

○ The cost/budget proposal will be requested in Phase II and must include a cost narrative and cost breakdown to complete each milestone in the milestone plan submitted (A cost breakdown sample will be provided in the invitation)

● Phase III - Negotiation and Other Transactions (OT) Award (Invitation Only)

○ This phase is by invitation only

○ Upon favorable evaluation and available funds, the NIH will proceed to negotiation and award with one proposer to make an OT Award.

Notional Timeline for the Biobank Award

Nov 18, 2024 ROA Release

11/18/2024–12/27/2024

Phase I Proposal Preparation & Submission

Dec 27, 2024 Proposals Due

12/30/24–2/27/2025

Phase I Proposal Review & Selection

Feb 28, 2025 Phase II Invitations Delivered to Selected Proposers

2/28/2025–3/31/2025

Phase II Demonstration Preparation by Selected

Proposers

Apr 1, 2025 Final Selection Decision Made for Phase III

4/2/2025–4/30/2025

Phase III Selection & Negotiation

May 1, 2025 Award

Questions & Answers

Question & Answers: MPIs and Phase I

1. Question: There are 2 new directors identified and being hired but they won’t be available before the submission deadline. They’ll be MPIs and we would like to include them in the Phase I submission. Is this acceptable?

Answer: Proposers are not required to have Directors/MPIs onboarded at the time of Phase I submission. You may include the new hires in your Phase I proposal.

Closing

• ROA Informational Webinar slides and Questions and Answers will be posted as an amendment on the ROA on SAM.gov

• Follow this opportunity on SAM.gov to get notifications to amendments

• Email any inquires to AllofUsDCDAwardRequirements@nih.gov

• Questions must be submitted to the email address listed in section

2.1 at least on or before Friday, 13 December 2024, 3pm EST.

Questions received after the deadline will not be answered.

https://sam.gov/opp/4eac2ee5bbd14675a4a977ea917cbe0d/view mailto:AllofUsDCDAwardRequirements@nih.gov

Thank You!

https://www.joinallofus.org/ AllofUs.nih.gov

@AllofUsResearch #JoinAllofUs https://www.joinallofus.org/ https://allofus.nih.gov/

All of Us Research Program Research Opportunity Announcement Informational Webinar ROA No. OTA-25-002

All of Us Biobank

Thank You!